MAUDE Adverse Event Report: SYNTHES GMBH DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS; GAUGE, DEPTH

Catalog Number	03.111.005
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screwdriver stripped star.Another screwdriver shaft tips are torqued/damaged.The depth gauge won't slide.No operation involved.No patient involvement.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h3, h6: part: 03.111.005-us.Lot: 821p191.Manufacturing site: hägendorf.Release to warehouse: 09-jun-2022.A dhr evaluation was performed for the finished device article #03.111.005-us lot #821p191, and no non-conformances were identified.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found to be bent from the needle.This issue can be related with the unable to assemble allegation.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the depth gauge for 2.0/2.4 and 2.7 screws would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: DEPTH GAUGE FOR 2.0MM/2.4MM AND 2.7MM SCREWS
• Common Device Name: GAUGE, DEPTH
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25579277
• Report Number: 8030965-2026-06418
• Device Sequence Number: 8975299
• Product Code: HTJ
• UDI-Device Identifier: 10886982072078
• UDI-Public: (01)10886982072078(10)821P191
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.111.005
• Device Lot Number: 821P191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown